BALMEX DIAPER RASH  - zinc oxide cream 
MOBERG PHARMA NORTH AMERICA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients Purpose
Zinc Oxide 11.3%Skin protectant

Uses

  • Helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only                

When using this product

  • do not get into eyes.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other information

  • do not use if quality seal is broken
  • see bottom of carton and or top of tube for lot number and expiration date

Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

Questions?

1-800-345-0032

Distributed by
Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
© 2015 All Rights Reserved. Made in Canada.

PRINCIPAL DISPLAY PANEL

NEW LOOK-SAME PRODUCT

Balmex®

COMPLETE PROTECTION™

Zinc Oxide
Diaper Rash Cream
Crema Para Dermatitis del Pañal

Advanced Formula

Prevents
✓ Protects against all 3 leading causes of diaper rash

Heals
✓ Reduces rash in just 1 diaper change

Pediatrician Recommended

Trusted by Moms for over 50 years

NET WT 16 OZ (453 g)

Questions? / Preguntas?
1-800-345-0032
Distributed by
Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
© 2015 All Rights Reserved. Made in Canada.
81-3910-04

www.balmex.com

16 oz. jar

NEW LOOK-SAME PRODUCT

Balmex®

COMPLETE PROTECTION™

Zinc Oxide
Diaper Rash Cream
Crema Para Dermatitis del Pañal

Prevents & Heals

✓ Protects against all 3 leading causes of diaper rash

✓ Reduces rash in just 1 diaper change

Pediatrician Recommended

Advanced Formula

NET WT 2 OZ (56 g)

EXTRA PROTECTION
for your baby's comfort

Balmex Complete Protection™ protects against all 3 leading causes of diaper rash to help keep your baby comfortable and rash-free.

IT PROTECTS AGAINST:
Diaper Wetness
Skin Chafing
PLUS
Digestive Enzymes found in dirty diapers that irritate skin

Balmex's Advanced Formula is designed to help stop the rash before it starts by providing extra protection against skin irritation. If a rash develops, Balmex will work quickly to relieve discomfort and help heal the rash. In fact, a clinical study shows that Balmex Complete Protection™ reduces diaper rash in just 1 diaper change.

Balmex contains the #1 Doctor recommended ingredient for the treatment of diaper rash plus soothing vitamins B5 and E. It goes on smoothly allowing for gentle application and removal to keep baby's delicate skin comfortable.

Recommended by Pediatricians & Trusted by Moms for over 50 years.

Questions? / Preguntas?
1-800-345-0032

©2016 Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927
All Rights Reserved. Made in Canada.

82-3901-03

www.balmex.com

2 oz carton

NEW LOOK- SAME PRODUCT

Balmex®
COMPLETE PROTECTION

Zinc Oxide
DIAPER RASH CREAM
Crema Para Dermatitis del Pañal

Prevents & Heals

✓Protects against all 3 leading causes of diaper rash

✓Reduces rash in just 1 diaper change

Advanced Formula

NET WT 0.18oz

Distributed by Moberg Pharma North America LLC
Cedar Knolls, NJ 07927, © 2016
All Rights Reserved. Made in Canada.

81-3912-03

www.balmex.com

SAMPLE - NOT FOR RESALE

Sample
BALMEX DIAPER RASH  
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-908
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide.113 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Yellow Wax (UNII: 2ZA36H0S2V)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Dimethicone 100 (UNII: RO266O364U)  
Soybean Oil (UNII: 241ATL177A)  
Magnesium Aspartate Anhydrous (UNII: 082H981FMA)  
Methylparaben (UNII: A2I8C7HI9T)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
Mineral Oil (UNII: T5L8T28FGP)  
Oenothera Biennis (UNII: 76UI55V071)  
Olea Europaea Leaf (UNII: MJ95C3OH47)  
Dexpanthenol (UNII: 1O6C93RI7Z)  
Potassium Aspartate (UNII: OC4598NZEQ)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Sarcosine (UNII: Z711V88R5F)  
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
Tocopherol (UNII: R0ZB2556P8)  
Water (UNII: 059QF0KO0R)  
Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)  
White Wax (UNII: 7G1J5DA97F)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16864-908-011 in 1 CARTON04/27/201505/31/2021
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:16864-908-02453 g in 1 JAR; Type 0: Not a Combination Product04/27/201506/30/2021
3NDC:16864-908-031 in 1 CARTON04/27/201502/28/2021
356 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:16864-908-045.1 g in 1 PACKAGE; Type 0: Not a Combination Product02/25/201601/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/27/201506/30/2021
Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)

Revised: 5/2019
 
MOBERG PHARMA NORTH AMERICA LLC